Trial Outcomes & Findings for A Study of TAK-994 in Adults With Narcolepsy (NCT NCT04820842)
NCT ID: NCT04820842
Last Updated: 2023-12-26
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)
Results posted on
2023-12-26
Participant Flow
Participants took part in the study at 13 investigative sites in Spain, Italy, Japan, Korea, and the United States from 30 April 2021 to 03 November 2021 \[early termination date\].
Participants with narcolepsy type 1 (NT 1) who completed Part B of TAK-994-1501(NCT04096560) were enrolled in this study to receive TAK-994 or placebo.
Participant milestones
| Measure |
Active Drug Extension Period: TAK-994 30 mg
TAK-994 30 mg, twice daily (BID) tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: TAK-994 30 mg
Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Double-blind Randomized Withdrawal Period: TAK-994 90 mg
Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Double-blind Randomized Withdrawal Period: TAK-994 180 mg
Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|---|---|---|
|
Active Drug Extension Period (8 Weeks)
STARTED
|
8
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Active Drug Extension Period (8 Weeks)
COMPLETED
|
5
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Active Drug Extension Period (8 Weeks)
NOT COMPLETED
|
3
|
8
|
7
|
0
|
0
|
0
|
0
|
|
Randomized Withdrawal Period (4 Weeks)
STARTED
|
0
|
0
|
0
|
3
|
1
|
1
|
3
|
|
Randomized Withdrawal Period (4 Weeks)
COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
|
Randomized Withdrawal Period (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active Drug Extension Period: TAK-994 30 mg
TAK-994 30 mg, twice daily (BID) tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: TAK-994 30 mg
Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Double-blind Randomized Withdrawal Period: TAK-994 90 mg
Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Double-blind Randomized Withdrawal Period: TAK-994 180 mg
Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|---|---|---|
|
Active Drug Extension Period (8 Weeks)
Adverse Event
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Active Drug Extension Period (8 Weeks)
Study Terminated by Sponsor (ongoing participants in this period were discontinued)
|
3
|
6
|
5
|
0
|
0
|
0
|
0
|
|
Active Drug Extension Period (8 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Randomized Withdrawal Period (4 Weeks)
Study Terminated by Sponsor (ongoing participants in this period were discontinued)
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
Baseline Characteristics
A Study of TAK-994 in Adults With Narcolepsy
Baseline characteristics by cohort
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=9 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 12.13 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 9.75 • n=7 Participants
|
29.7 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 10.56 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, South
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Height
|
163.9 centimeters (cm)
STANDARD_DEVIATION 8.39 • n=5 Participants
|
170.5 centimeters (cm)
STANDARD_DEVIATION 8.24 • n=7 Participants
|
174.4 centimeters (cm)
STANDARD_DEVIATION 6.45 • n=5 Participants
|
169.8 centimeters (cm)
STANDARD_DEVIATION 8.58 • n=4 Participants
|
|
Weight
|
76.5 kilograms (kg)
STANDARD_DEVIATION 18.52 • n=5 Participants
|
81.8 kilograms (kg)
STANDARD_DEVIATION 22.68 • n=7 Participants
|
79.1 kilograms (kg)
STANDARD_DEVIATION 16.15 • n=5 Participants
|
79.2 kilograms (kg)
STANDARD_DEVIATION 18.68 • n=4 Participants
|
|
Body Mass Index (BMI)
|
28.3 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 5.86 • n=5 Participants
|
27.7 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 5.45 • n=7 Participants
|
25.9 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 5.07 • n=5 Participants
|
27.3 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 5.33 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)Population: Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=9 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)Population: Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.
Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin \<0.8×lower limit of normal (LLN), \>1.2×upper limit of normal (ULN); Hematocrit \<0.8×LLN, \>1.2×ULN; Red blood cells (RBC) count \<0.8×LLN, \>1.2×ULN; White blood cells (WBC) count \<0.5xLLN, \>1.5xULN; Platelet count \<75x10\^9/liter (L), \>600x10\^9/L; alanine aminotransferase (ALT) \>3xULN; aspartate aminotransferase (AST) \>3xULN; gamma-glutamyl transferase (GGT) \>3xULN; Alkaline phosphatase \>3xULN; Total bilirubin \>1.5xULN; Albumin \<25 grams per liter (g/L); Total protein \<0.8xLLN, \>1.2xULN; Creatinine \>1.5xULN; Blood urea nitrogen \>40 milligrams per deciliters (mg/dL); Sodium \<130 milliequivalents per liter (mEq/L), \>150 mEq/L; Potassium \<3.0 millimoles per liter (mmol/L), \>5.3 mmol/L; creatine phosphokinase (CPK) \>3xULN; Glucose \<50 mg/dL, \>300 mg/dL; Calcium \<7.7 mg/dL, \>11.1 mg/dL. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=9 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
ALT: >3 x ULN
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
AST: >3 x ULN
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
Bilirubin: >1.5 x ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
GGT: >3 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
Potassium: >5.3 mmol/L
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)Population: Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.
MAV criteria for vital signs were: Pulse \<40 beats per minute (bpm), \>115 bpm; Systolic blood pressure \<90 millimeters of mercury (mmHg), ≥160 mmHg; Diastolic blood pressure \<50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of \>20, \>30 mmHg from Baseline, Body temperature \>38.5 degree Celsius, Respiratory Rate \>21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Active Drug Extension Period.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=9 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Systolic Blood Pressure: <90 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Systolic Blood Pressure: ≥160 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Systolic Blood Pressure: Change from Pre-Dose >20 mmHg
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Systolic Blood Pressure: Change from Pre-Dose >30 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Diastolic Blood Pressure: ≥100 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Diastolic Blood Pressure: Change from Pre-Dose >20 mmHg
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Diastolic Blood Pressure: Change from Pre-Dose >30 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Respiratory Rate: >21 breaths/minute
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)Population: Safety Analysis Set for the Active Drug Extension Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period.
MAV criteria for ECG were: Heart rate \<40 bpm, \>115 bpm; PR interval ≤80 milliseconds (msec), ≥200 msec; QT interval with Fridericia correction method (QTcF) Interval ≤300 msec, \>500 msec or ≥30 msec change from baseline and \>450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=9 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period
Heart Rate: <40 bpm
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period
PR Interval: ≥200 msec
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period
QRS Duration: ≤80 msec
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)Population: Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period.
An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=3 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=1 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=1 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
n=3 Participants
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One TEAE During the Double-blind Randomized Withdrawal Period
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)Population: Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period.
Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin \<0.8×LLN, \>1.2×ULN; Hematocrit \<0.8×LLN, \>1.2×ULN; RBC count \<0.8×LLN, \>1.2×ULN; WBC count \<0.5xLLN, \>1.5xULN; Platelet count \<75x10\^9/L, \>600x10\^9/L; ALT \>3xULN; AST \>3xULN; GGT \>3xULN; Alkaline phosphatase \>3xULN; Total bilirubin \>1.5xULN; Albumin \<25 g/L; Total protein \<0.8x LLN, \>1.2xULN; Creatinine \>1.5xULN; Blood urea nitrogen \>40 mg/dL; Sodium \<130 mEq/L, \>150 mEq/L; Potassium \<3.0 mmol/L, \>5.3 mmol/L; CPK \>3xULN; Glucose \<50 mg/dL, \>300 mg/dL; Calcium \<7.7 mg/dL, \>11.1 mg/dL.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=3 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=1 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=1 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
n=3 Participants
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Post-dose MAV in Laboratory Test During the Double-blind Randomized Withdrawal Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)Population: Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period.
MAV criteria for vital signs were: Pulse \<40 bpm, \>115 bpm; Systolic blood pressure \<90 mmHg, ≥160 mmHg; Diastolic blood pressure \<50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of \>20, \>30 mmHg from Baseline, Body temperature \>38.5 degree Celsius, Respiratory Rate \>21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Double-blind Randomized Withdrawal Period (Day 57 of this study).
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=3 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=1 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=1 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
n=3 Participants
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period
Systolic Blood Pressure: <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period
Systolic Blood Pressure: Change from Baseline >20 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period
Diastolic Blood Pressure: Change from Baseline >20 mmHg
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)Population: Safety Analysis Set for the Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Double-blind Randomized Withdrawal Period.
MAV criteria for ECG were: Heart rate \<40 bpm, \>115 bpm; PR interval ≤80 msec, ≥200 msec; QTcF Interval ≤300 msec, \>500 msec or ≥30 msec change from baseline and \>450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Active Drug Extension Period: TAK-994 30 mg
n=3 Participants
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 90 mg
n=1 Participants
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Active Drug Extension Period: TAK-994 180 mg
n=1 Participants
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Double-blind Randomized Withdrawal Period: Placebo
n=3 Participants
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Post-dose MAV for ECG Parameters During the Double-blind Randomized Withdrawal Period
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Period 1: TAK-994 30 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 1: TAK-994 90 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 1: TAK-994 180 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2: TAK-994 30 mg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 2: TAK-994 90 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 2: TAK-994 180 mg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 2: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: TAK-994 30 mg BID
n=8 participants at risk
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Period 1: TAK-994 90 mg BID
n=9 participants at risk
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Period 1: TAK-994 180 mg BID
n=9 participants at risk
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Period 2: TAK-994 30 mg BID
n=3 participants at risk
Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Period 2: TAK-994 90 mg BID
n=1 participants at risk
Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Period 2: TAK-994 180 mg BID
n=1 participants at risk
Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Period 2: Placebo
n=3 participants at risk
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
Other adverse events
| Measure |
Period 1: TAK-994 30 mg BID
n=8 participants at risk
TAK-994 30 mg, BID tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Period 1: TAK-994 90 mg BID
n=9 participants at risk
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Period 1: TAK-994 180 mg BID
n=9 participants at risk
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
|
Period 2: TAK-994 30 mg BID
n=3 participants at risk
Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Period 2: TAK-994 90 mg BID
n=1 participants at risk
Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Period 2: TAK-994 180 mg BID
n=1 participants at risk
Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
|
Period 2: Placebo
n=3 participants at risk
Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
22.2%
2/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
100.0%
1/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
33.3%
1/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
100.0%
1/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Nervous system disorders
Migraine
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
100.0%
1/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Infections and infestations
Oral herpes
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
General disorders
Temperature intolerance
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
11.1%
1/9 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/1 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
0.00%
0/3 • From randomization up to two weeks post end of treatment (up to Week 14)
Safety Analysis Set for the Active Drug Extension Period and Double-blind Randomized Withdrawal Period included all participants who were randomized and received at least 1 dose of study drug in the Active Drug Extension Period and Double-blind Randomized Withdrawal Period respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER